Home
Publications
Risk & Compliance
Training
Audit & Certify
About Us
Daily Promotions
Instructor-Led Courses
> Six Sigma
> Lean Enterprise
> Process Management
> Information Security
> ISO 9001:2000
> ISO 14001 / OHSAS 18001
> AS9100 / AS9110
> Medical Device - ISO 13485
> Pharmaceutical
> ISO/TS 16949
> ISO/IEC 17025
> TL 9000
> Food Safety
> Malcolm Baldrige
> Project Management
Course Calendar
e-Learning
Video / CD-ROM
> Basic Six Sigma Skills
> Corrective Action
> Becoming Lean
> Achieving Excellence
> ISO 9000 Internal Auditing
> Basic Statistical Process Control
> Masters Statistical Process Control
> Design of Experiments
> Quality Function Deployment
> GD&T
> Basic Measuring Tools
> Coordinate Measuring Machines
> Blueprint Reading
> Basic Shop Math
> Applied Shop Math
> Conflict Management for Teams
> Self-Directed Teams
Business Improvement
Contact Us
Daily Promotions
Instructor-Led Courses
> Six Sigma
> Lean Enterprise
> Process Management
> Information Security
> ISO 9001:2000
> ISO 14001 / OHSAS 18001
> AS9100 / AS9110
> Medical Device - ISO 13485
> Pharmaceutical
> ISO/TS 16949
> ISO/IEC 17025
> TL 9000
> Food Safety
> Malcolm Baldrige
> Project Management
Course Calendar
e-Learning
Video / CD-ROM
Business Improvement
Contact Us
Understanding FDA Regulations for Combination Products
Course 0726 - 2 Days - 1.4 CEUs
Call for pricing at your location.
Key Session Topics
What the FDA expects now
A detailed look at requirements: 21CFR820 and 210/211
Issues with meeting multiple requirements
FDA concerns with combination products
Why SAI Global?
Our courses teach
real-world business objectives
in an
interactive learning environment
.
Our instructors have an average of
20 years industry experience
.
We offer
excellent customer service
.
We have maintained a
98.9% approval rating among more than 200,000 training participants
.
If you have questions about this course,
submit a
Course Information Request
or call us at 1-800-374-3818.
To learn about the savings and instructional benefits of training five or more participants at your location, submit an
On-Site Quote Request
or call us at 1-800-374-3818.
To learn how you can save 10% - 30% on course registrations with SAI Global as your preferred training provider, submit a
Customer Rewards Request
or call us at 1-800-374-3818.
Course Objectives
This course provides the information needed to meet the required regulations for medical products that are a combination device/drug. Learn how to deal with the differing requirements between 21CFR820 and 21CFR210/211 and still have a practical Quality Management System. Attendees will gain a thorough understanding of what is required for devices and drugs through analysis of the FDA requirements specified in 21CFR820 and 21CFR210/211 and related CFRs as applicable.
What You Will Learn
Understand how to meet both 21CFR820 and 210/211 without confusing personnel
Keep documentation to a minimum, while still meeting requirements
Bring new or enhanced combination products to market faster with less risk and higher quality
Demonstrate to regulatory agencies that products are developed and produced under controlled processes, assuring safety and effectiveness
Minimize product liability related risks
Who Should Attend
R&D managers/engineers
RA/QA managers/engineers
Manufacturing/Production managers/engineers
Management representatives
Sales and marketing management
Product, project, program managers
Internal auditors